Research Protocol April 14

BACKGROUND AND SIGNIFICANCE

Chronic obstructive pulmonary disease (COPD) is a major public health issue because the course of the disease is progressive and imposes considerable demand on patients as well as healthcare systems (1). The airflow limitation in this disease and the presence of symptoms such as chronic cough, shortness of breath, and progressive difficulty in breathing are what clinically define COPD. This disease is a complex process represented by chronic bronchitis and emphysema caused by exposure to toxic particles or gases, mainly cigarette smoke (Global Initiative for Chronic Obstructive Lung Disease (2, 3). COPD consistently is the third cause of death killing more than 3 million lives per year. (1). Smoking is still the main cause of COPD. However, other environmental pollutants, hereditary background, and infection with respiratory viruses also add to the burden of this disease. Over a long period of time, the progressive expansion occurs gradually and results in worsening symptoms and a significant decrease in quality of life (4). Managing COPD calls for a holistic approach that involves screening for early signs, smoking cessation, utilizing drug therapy, and involving people in pulmonary rehabilitation (2).

Epidemiological studies stated that 20-40% of all COPD cases never smoked previously, so consideration of other factors such as occupational hazards etc, contradictory to other studies (5). COPD is a most prevalent disease in the New York state, with the prevalence of 900,000 individuals. Data from the BREFSS indicates that 5.3% adults of the New York have COPD. The Centers for Disease Control and Prevention (2022) reports that the prevalence varies according to smoking status, with rates greatest among current smokers (13.1%), followed by former smokers (9.5%), and lowest among those who have never smoked (2%). Although long-term exposure to air pollution is one of the main causes of COPD, accounting for the majority of cases, smoking is still the key contributing factor (6).

The clean indoor air laws of New York City and the increase in cigarette taxation have gone a long way in alleviating smoking, but they have sometimes resulted in tax-avoidance behaviors such as buying discounted packs and individual cigarettes ("loosies") from street vendors. This is especially common in the urban areas and among low-income minority populations. Findings indicate that “loosie” cigarette presence often leads to smoking and assists in the lapse episodes, especially among non-daily smokers (7). In the New York state, there are many smoking control programmes (Smoking‐Attributable Mortality, Morbidity, and Economic Costs (SAMMEC) model, Monograph 21: The Economics of Tobacco and Tobacco Control) working to reduce the burden of the smoking and the smoking related respiratory complaints (8). Even with these improvements, smoking still has a significant negative impact on the health of the individual. About 21,000 New Yorkers lost their lives to smoking-related illnesses such as the chronic respiratory complaints in 2017, and the state's substantial medical expenses came to $9.73 billion (9).

The main purpose of this research is to find out the relationship between different smoking patterns (for instance, pack years and years of smoking) and COPD development and progress among adults over the age of 40 who live in Brooklyn, New York. The purpose of this research is to improve our understanding of how smoking behaviors and risk of developing COPD work synergistically within the urban setting. Finally, results from this study will guide the development of community-driven interventions and public health campaigns for minimizing COPD prevalence and its burden being found in other urban areas like Brooklyn.

1. To Evaluate the Association Between Smoking Intensity (Pack Years) and COPD Risk:

Hypothesis: The research will be conducted to support the conclusion that smoking more than a pack a day, measured in terms of pack years will significantly increase one’s chance of getting diagnosed with COPD above the age of 40 among adults in Brooklyn, New York.

Study design:

The study design is a retrospective case-control study to assess the relationship between smoking history and COPD in individuals 40 years and over from Brooklyn, New York. Healthcare data will be collected from several centers, such as hospitals and clinics in Brooklyn, NY. There will be no use of medicines, devices, or procedures that medicate. Data extraction will facilitate filling in forms with frequent patients’ history of smoking and their COPD diagnosis.

Study Population:

The data for this study will be collected from the Brooklyn Hospital Center Chronic Obstructive Pulmonary Disease (COPD). Demographic information in the forms of age, sex, and race will be extracted from the medical records of the ones who are participants. As well as patients with COPD that are already diagnosed by their professionals on the basis of spirometry results shall form part of the research.

Inclusion Criteria:

1. Adult aged 40 years or above

2. Already diagnosed COPD cases from the Brooklyn Hospital Center Chronic Obstructive Pulmonary Disease (COPD).

3. Patients having medical records that include relevant details about their age, gender, smoking history, spirometry results, and other clinical data.

4. Willingness to participate

5. Patients who provide consent for their anonymized medical records to be used for research purposes.

Exclusion Criteria:

1. Adult added below 40 years

2. Diagnosed with other respiratory issues other than the COPD

3. Patients with incomplete medical records

4. Not willing to participate in the study

5. Patient with co-morbidities

Then after identifying the participants, there will be one study visit scheduled for them which will probably not last more than 1-2 hours at Brooklyn Hospital Center Chronic Obstructive Pulmonary Disease (COPD). During the visit, structured interviews will be carried out without interruption for the collection of demographic information including age, sex, address, name, medical history will be consulted, smoking and alcohol history, and diagnoses of COPD. Thorough assessment will be conducted by who will administer standardized questionnaires to assess smoking history, respiratory symptoms, and quality of life. The trial, however, does not entail biology-based sample collection or drug administration. Retrospectively, patient data will be obtained from medical records and carefully shielded from any possibilities of personal identity revelation. Highly detailed training courses will be given to everyone throughout the project so that the research protocol can be followed, and ethical guidelines adhered to. Continuous supervision and support can be used iteratively to solve the problems that may be realized at the data collection stage.

Data collection in the research proposal technique is successively carried out by identifying the adult participants from Brooklyn Hospital Center Chronic Obstructive Pulmonary Disease (COPD) in New York. Using directed interviews, self-reports, and medical record reviews data on smoking status, demographics, COPD diagnosis through the spirometry results, comorbidities, medication, and clinical variables will be collected. Research personnel are the ones who will administer the interviews and ensure the validity of the data. All data are going to be secured and ethical conduct will be adhered to in which way informed consent and Institutional Review Board approval will be obtained.

Smoking History:

Tobacco history is estimated by both self-reporting and the patients' medical records. Participants will provide information about smoking status in particular (current smoker, former smoker or never smoked), number of cigarettes smoked every day, and duration in years when they started to smoke. Pack-years, the measure of smoking intensity, will be calculated by multiplying the number of packs daily smoked by the number of years smoked (10).

Smoking Duration:

The Duration of Cigarette Smoking is about the number of years an individual has smoked tobacco cigarettes. It will be evaluated by questionnaires and medical records too to ascertain correctness. The question would be asked of the participants to provide the age at which they started with regular smoking and the age at which they accompanied the smoking (11). We will use this data to compute the total number of years that the interviewee smoked. Smoking duration is crucial in measurement of the amount of smoke exposure.

DATA ANALYSIS

STUDY LIMITATIONS

ETHICAL CONSIDERATIONS

In addition, the researchers must see to it that the study is as ethical as possible and that it follows all ethical rules and regulations, such as those set forth by institutional review boards (IRBs), ethics committees, or other authorized bodies. This includes obtaining approval from the ethics committee and also the right ethical review board before initiating data collection. The researcher will also be required to ensure that the test plan minimizes any potential harm or discomfort to the participants.

In addition to that, the openness and truthfulness must be kept up with while handling all components of the study such as disclosure of any conflicts of interest, honest representation of the researchers' purposes and the research methodology to the participants. Besides that, the researchers should emphasize the safety of the participants and try to reach the greatest positive effects of the experiment while reducing any risk.

PLANS FOR DISSEMINATION OF FINDINGS:

The results of this study will be communicated through different mediums like publication in scientific journals, and presentations in academic forums and the stakeholders will be informed about the results. Lastly, their findings may be communicated to participants and the wider community through community workshops, plain language summaries, or any simple means to reach out.